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NCT00708110 · ClinicalTrials.gov registry record · Phase 2

Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults

A Phase 2 study, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 2
Development phase
35
Enrollment target

NCT00708110: Completed Phase 2 study, sponsored by ViiV Healthcare.

NCT00708110 is a Phase 2 study that has completed, run by ViiV Healthcare. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00708110, a Phase 2 study, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 2
Development phase
35 participants
Enrollment target

Study Summary

GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging, placebo-controlled 'proof of concept' study is to be conducted to compare antiviral effect, safety, tolerability, and pharmacokinetics of GSK1349572 monotherapy versus placebo over 10 days in ART-naïve and experienced, but integrase inhibitor naïve (meaning never having had an integrase inhibitor) HIV-1 infected adults who are not currently receiving antiretroviral therapy. This study consists of a screening visit, a treatment period and a follow-up evaluation. Thirty subjects will be randomized to receive one of three doses of GSK1349572 or placebo q24h over 10 days. Antiviral effect measures include viral load and CD4 cell count.

Primary Outcome

Change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) was calculated as the Day 11 value minus the Baseline value. Blood samples for the measurement of HIV-1 RNA levels were obtained throughout the treatment period (Day 1 to Day 11).

Interventions

  • DRUG Placebo
  • DRUG GSK1349572

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2008-06
Est. Completion 2008-08
Phase Phase 2
ViiV Healthcare

182 total trials

What the finished NCT00708110 record still lists

NCT00708110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00708110 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00708110 about?

NCT00708110 is a clinical study titled "Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults". GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging, placebo-controlled 'proof of concept' study is to be conducted to compare antiviral effect, safety, tolerability, and pharmac...

What is the current status of trial NCT00708110?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2008-06. Estimated completion is 2008-08.

What interventions are being tested in trial NCT00708110?

The interventions under investigation include: Placebo (DRUG), GSK1349572 (DRUG).

Who is sponsoring clinical trial NCT00708110?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00708110's enrollment target sits among peer trials

35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00708110, the US trial registry maintained by the National Library of Medicine. NCT00708110 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.